Trial Information

OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or
metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and
gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin
calcium, and gemcitabine in these patients.

OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium
for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine
infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is
increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II
proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients
experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to
be considered evaluable for response. Patients with stable disease, partial, or complete
remission may continue therapy for up to six treatment cycles. Patients exhibiting disease
progression or intolerable toxic effects are removed from the study.

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